Vaccines and immunotherapeutics derived from the human immunodeficiency virus ( HIV) trans-activator of transcription protein for the treatment and prevention of HIV disease

Abstract

Anti-lentivirus vaccines and immunotherapeutics and methods for preparing and using same are disclosed. The vaccines and immunotherapeutics are produced using non-immunosuppressive lentivirus trans-activator of transcription (Tat) proteins. An associated in vitro ultra-sensitive macrophage Tat bioassay is disclosed for assessing the immunosuppressive qualities of the lentivirus Tat preparations of the present invention. Additionally, a related long-term T4 cell propagation system for characterizing lentivirus Tat is also disclosed. The present invention has additional utility in the treatment and prevention of AIDS.

I claim:  
     
         1 . A lentivirus vaccine comprising: 
 a non-immunosuppressant lentivirus trans-activator (Tat) protein.    
     
     
         2 . The lentivirus vaccine of  claim 1  wherein said lentivirus is a human lentivirus, or portions thereof.  
     
     
         3 . The lentivirus vaccine of  claim 1  wherein said lentivirus is Human Immunodeficiency Virus (HIV) or portions thereof.  
     
     
         4 . A lentivirus immunotherapeutic comprising: 
 an non-immunosuppressant lentivirus trans-activator (Tat) protein.    
     
     
         5 . The lentivirus immunotherapeutic of  claim 4  wherein said lentivirus is a human lentivirus or portions thereof.  
     
     
         6 . The lentivirus immunotherapeutic of  claim 4  wherein said human lentivirus is Human Immunodeficiency Virus (HIV) or portions thereof.  
     
     
         7 . The lentivirus immunotherapeutic of  claim 4  wherein said non-immunosuppressant lentivirus Tat protein is Tat protein treated with an oxidizing agent.  
     
     
         8 . The lentivirus immunotherapeutic of  claim 4  wherein said non-immunosuppressant lentivirus Tat protein is a Tat protein associated with HIV long term non-progressors (LTNP).  
     
     
         9 . A vaccine adjuvant comprising non-immunosuppressant lentivirus trans-activator (Tat) protein.  
     
     
         10 . The vaccine adjuvant of  claim 9  wherein said non-immunosuppressant lentivirus trans-activator (Tat) protein is Tat protein treated with an oxidizing agent.  
     
     
         11 . The vaccine adjuvant of  claim 9  wherein said non-immunosuppressant lentivirus trans-activator (Tat) protein is a Tat protein associated with HIV long term non-progressors (LTNP).  
     
     
         12 . A treatment for lentivirus diseases comprising administering a non-immunosuppressant lentivirus trans-activator (Tat) protein to a lentivirus infected mammal.  
     
     
         13 . The treatment for lentivirus diseases of  claim 15  wherein said lentivirus disease is HIV disease.  
     
     
         14 . The treatment for lentivirus diseases of  claim 12  wherein said HIV disease is acquired immune deficiency syndrome.  
     
     
         15 . The treatment for lentivirus diseases of  claim 12  wherein said non-immunosuppressant lentivirus trans-activator (Tat) protein is Tat derived from LTNP.  
     
     
         16 . The treatment for lentivirus diseases of  claim 12  further comprising administering to an HIV infected mammal viable HIV isolated from a LTNP that reproduces in said HIV infected mammal and produces non-immunosuppressant Tat.  
     
     
         17 . The treatment for lentivirus diseases of  claim 12  further comprising administering a Tat TcL cell line which produces a non-immunosuppressant lentivirus trans-activator (Tat) protein to a lentivirus infected mammal.  
     
     
         18 . An in vitro ultra-sensitive macrophage Tat bioassay comprising: 
 a substantially pure population of macrophage cells exposed to Tat; and    measuring the said macrophage cell's expression of FasL.    
     
     
         19 . A long-term T4 cell propagation system comprising: 
 a substantially diluted co-culture of non infected peripheral blood mononuclear cells (PBMC) and PBMCs isolated from HIV infected individuals which express IS-Tat.    
     
     
         20 . A method for characterizing lentivirus Tat comprising the steps, of; 
 a) providing a co-culture of non-infected peripheral blood mononuclear cells (PBMC) and PBMCs isolated from HIV infected individuals;    b) diluting said co-culture to a very low density such that culture conditions would normally kill primary T4 cells;    c) monitoring said co-culture for presence of Lentivirus infection;    d) detecting the presence Tat proteins; and    e) determining the immunosuppressive qualities of said detected Tat protein.